Daily Meditation Program in Women Admitted to the Antepartum Unit

NCT ID: NCT03737279

Last Updated: 2020-06-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-04

Study Completion Date

2020-04-01

Brief Summary

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The purpose of this study is to assess whether a daily mindful meditation program for women admitted to the antepartum floor will decrease maternal state anxiety compared to routine care.

Detailed Description

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Conditions

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Pregnancy, High Risk Pregnancy Related

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Meditation

Intervention Group:

Routine care plus twice daily mindful meditation

Group Type EXPERIMENTAL

Meditation

Intervention Type BEHAVIORAL

Routine care + twice daily meditation per schedule, to start on the day of randomization

Routine Care

Intervention Type BEHAVIORAL

Routine care including ACOG educational pamphlets:

* Day 1: "Nutrition in Pregnancy"
* Day 2: "Heart Health for Women"
* Day 3: "Exercise after Pregnancy"

Routine care

Control Group:

Routine care which includes ACOG educational pamphlets on day 1, 2 and 3 after randomization

Group Type ACTIVE_COMPARATOR

Routine Care

Intervention Type BEHAVIORAL

Routine care including ACOG educational pamphlets:

* Day 1: "Nutrition in Pregnancy"
* Day 2: "Heart Health for Women"
* Day 3: "Exercise after Pregnancy"

Interventions

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Meditation

Routine care + twice daily meditation per schedule, to start on the day of randomization

Intervention Type BEHAVIORAL

Routine Care

Routine care including ACOG educational pamphlets:

* Day 1: "Nutrition in Pregnancy"
* Day 2: "Heart Health for Women"
* Day 3: "Exercise after Pregnancy"

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* ≥ 18 years of age
* ≥ 23.0 weeks gestation
* Planned inpatient care for \> 3 days from randomization
* Women cared for by UT physicians

Exclusion Criteria

* Known major lethal fetal anomalies (eg. trisomy 13, trisomy 18, anencephaly, Potter's Syndrome)
* Non-English speaking women
* Planned delivery ≤ 3 days from randomization
* Previous fetal surgery in the current pregnancy (twin twin transfusion syndrome laser ablation, spina bifida repair, etc)
* Women who have practiced a form of meditation in the current pregnancy (including yoga) in the last 4 weeks
* Women who are currently using patient-controlled analgesia (PCA) (eg. sickle cell crisis)
* Admission diagnosis of ecclampsia or HELLP (hemolysis, elevated liver enzymes, low platelets) syndrome
* Diagnosed personality disorder including borderline personality disorder, histrionic personality disorder, schizoid personality disorder, schizotypal personality disorder, schizophrenia
* Diagnosed anxiety, depression, bipolar or other psychiatric illness on medications for these disorders
* Non-reassuring fetal heart tracing on admission
* Intrauterine fetal demise at randomization
* Inability to gain access to phone application
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Morgen Doty

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Morgen S Doty, DO

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

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The University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status

Countries

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United States

References

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Doty MS, Chen HY, Ajishegiri O, Sibai BM, Blackwell SC, Chauhan SP. Daily meditation program for anxiety in individuals admitted to the antepartum unit: a multicenter randomized controlled trial (MEDITATE). Am J Obstet Gynecol MFM. 2022 May;4(3):100562. doi: 10.1016/j.ajogmf.2022.100562. Epub 2022 Jan 12.

Reference Type DERIVED
PMID: 35031521 (View on PubMed)

Other Identifiers

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HSC-MS-18-0810

Identifier Type: -

Identifier Source: org_study_id

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